Sr Director, Clinical Data Management

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.

We are seeking an innovative and strategic Senior Director in Clinical Data Management (CDM) to shape and scale data infrastructure for our clinical programs. This role will lead the end-to-end clinical data lifecycle across programs, driving excellence in data quality, integrity, and regulatory compliance-while also championing digital transformation, automation, and operational scalability. This is a high-impact leadership role suited for a bold, future-oriented data leader who is excited to help shape the digital future of clinical development in CareDx.

Key Responsibilities:

• Strategic and Operational Leadership
  • Lead the Clinical Data Management function, overseeing strategy, execution, compliance, and performance across all clinical programs. Develop, and mentor a high-performing CDM team.
  • Define and implement best practices, SOPs, and policies to support high-quality, audit-ready data deliverables.
• Digital Innovation & Automation
  • Champion the integration of AI/ML-powered tools, eSource, and real-time analytics platforms to streamline and modernize clinical data workflows.
  • Evaluate and implement cutting-edge EDC systems and data visualization dashboards to enable near real-time decision-making.
  • Lead initiatives to automate repetitive CDM processes (e.g., data cleaning, discrepancy management, coding), increasing efficiency and reducing manual errors.
• Scalability and Infrastructure
  • Design scalable data architecture to support multi-site, comprehensive trials, and post-launch studies, aligned with the company's growth trajectory.
  • Partner with IT, data engineering, and Clinical Operational teams to ensure seamless system interoperability (e.g., EDC, LIMS, data warehouse, etc.).
  • Develop scalable data governance and oversight models to accommodate complex and different study designs across clinical programs.
• Cross-Functional Collaboration
  • Work closely with Clinical Operations, Biostatistics, Data Science, Data Engineering, Regulatory Affairs, Quality, and IT to align on clinical data strategies.
  • Serve as CDM representative on study teams, clinical leadership, and digital innovation forums.
  • Contribute to submission planning (e.g., CDISC compliance, SDTM delivery) for Payor, Regulatory and other health authorities.

Qualifications & Experience

• Minimum Requirements
  • Advanced degree (MS/PhD preferred) in Life Sciences, Health Informatics, Biostatistics, or related field.
  • 7+ years of progressive experience in clinical data management, including 5+ years in a leadership role.
  • Proven track record leading CDM in regulated environments, including FDA/EMA audits, GLP/GCP compliance, and CDISC/CDASH standards.
• Preferred Experience & Skills
  • Experience in molecular diagnostics clinical trials.
  • Deep understanding of EDC systems (e.g., Medrio, Medidata Rave, Veeva) and associated integrations.
  • Demonstrated success in implementing automation tools or digital platforms in a clinical data environment.
  • Familiarity with data privacy regulations (HIPAA, GDPR) and 21 CFR Part 11 compliance.
  • Strategic thinker and hands on leader with the ability to lead team in high-growth, fast-paced settings.
  • Excellent communication and cross-functional leadership skills.

Remote: US only roles

The anticipated base salary range in the United States is $200,000 - $260,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.

Additional Details:

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• Pre-tax commuter benefits
• And more!

• Please refer to our page to view detailed benefits at https://caredx.com/company/careers/

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it's an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.

By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx.

******** We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.

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